161例细辛脑注射液新的严重不良反应/事件分析

摘要：目的 通过对近4年细辛脑注射液致不良反应/事件（ADR/ADE）报告进行回顾性分析，为临床合理用药提供参考。方法 对济南市药品不良反应监测中心2006-2009年收到的161例细辛脑注射液新的、严重（新严）的ADR/ADE报告表进行统计分析。结果 细辛脑注射液致161例新严的ADR/ADE病例，发生时间在用药20min以内的129例，占80.12%；主要累及和损害呼吸系统75例、消化系统73例、心脏及循环系统51例等；儿童为ADR/ADE的高发人群，占全部病例的49.69%。细辛脑注射液生产工艺中的辅料（增溶剂）、药物本身的稳定性、临床联合及配伍用药等是导致ADR/ADE的主要原因。结论 细辛脑注射液致临床ADR/ADE（特别是儿童）应引起高度重视；孕妇及哺乳期妇女禁用。临床医务人员应减少或避免严重ADR/ADE的发生；希望有关部门对该药品的安全性应进一步进行研究。

Analysis on 161 New or Serious Reports of Xixinnao Injection

Objective of the past 4 years Xixinnao injection adverse reaction/event（ADR/ADE） reports were reviewed,provide a reference for clinical medication.Methods Jinan ADR Monitoring Center received 161 cases 2006～2009 Xixinnao injection of new,serious（the new strict） of ADR/ADE reports were collected and analyzed.Results Xixinnao injection of 161 patients with new stringent ADR/ADE cases occurred within 20min of time in 129 drug cases,accounting for 80.12%;children as high risk group,accounting for 49.69% in all cases.Xixinnao injection production process of accessories,the stability of the drug itself,and the combination of clinical medicine such as the joint leading to ADR/ADE of the main reasons.Conclusion Xixinnao injection in clinical ADR/ADE should attract great attention of clinical medicine;proposed system for pharmacy instructions.Hope that the security departments of the drugs should be further studied.